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510(k) K881195

DYNATECH SPD 2000, NUMBER 002-910-0000 by Dynatech Laboratories, Inc. — Product Code JQW

K881195 is an FDA 510(k) premarket notification submitted by Dynatech Laboratories, Inc. for the device "DYNATECH SPD 2000, NUMBER 002-910-0000". The FDA issued a decision of Substantially Equivalent on June 7, 1988. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Dynatech Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1988
Date Received
March 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Pipetting And Diluting, For Clinical Use
Device Class
Class I
Regulation Number
862.2750
Review Panel
CH
Submission Type

Other clearances by Dynatech Laboratories, Inc.

  • K962265 — MLX MICROTITER PLATE LUMINOMETER (July 25, 1996)
  • K934111 — MR7000 WITH TIME MANAGER SOFTWARE (TMS) (November 2, 1994)
  • K943701 — MRX MICROPLATE READER (October 20, 1994)
  • K923456 — MICROLITE MICROTITER PLATE LUMINOMETER ML3000 (October 13, 1992)
  • K915896 — MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI (May 4, 1992)
  • K920888 — MICROLITE MICROTITER PLATE LUMINOMETER ML2200 (March 19, 1992)
  • K913590 — MICROLITE ML 1000 MICROTITER PLATE LUMINOMETER (October 25, 1991)
  • K895313 — MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER (October 17, 1989)
  • K894645 — IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (October 17, 1989)
  • K894687 — DYNATECH MR 5000, CATALOG #011-976-0600 (August 31, 1989)

Other clearances for product code JQW

  • K023955 — BD VIPER INSTRUMENT (June 24, 2003)
  • K973335 — QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (April 30, 1998)
  • K980180 — 2700 SAMPLE MANAGER (February 12, 1998)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K970616 — MINI SAMPLER PROCESSOR (April 21, 1997)
  • K962687 — GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (March 28, 1997)
  • K962859 — MINI SAMPLE PROCESSOR (October 29, 1996)
  • K961896 — MICROLAB 4000, MICROLAB 4200 (August 16, 1996)
  • K961694 — IMPACT (June 21, 1996)
  • K953345 — GENESIS (November 21, 1995)

FDA data resources